Hydration status monitor (HSM) product development

SOLICITATION # W81XHW-13-0046
AMENDMENT #01

The above referenced request for quotation is hereby amended to attach the Justification and Approval (J&A) document.


NOTICE OF INTENT TO SOLE SOURCE -- The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm-Fixed-Price sole source award under the authority of FAR 6.302-1 (2) (c) (ii) - Only one responsible source and no other supplies will satisfy agency requirements, on or about 19 July 2013, to GAIA Medical Institute LLC, 505 Coast Blvd South, La Jolla, California 920374614 on behalf of the sponsor agency of the United States Army Medical Materiel Agency (USAMMA).

The North American Industrial Classification System (NAICS) code for this acquisition is 541711 and the size standard is 500.

The purpose of this effort is to develop a Hydration Status Monitor (HSM) sensor(s) for insertion into existing field medical equipment sets for primary use by medical personnel at the Battalion Aid Station (BAS) level. It is anticipated that the HSM will receive Food and Drug Administration (FDA) marketing clearance at the end of this contract.

The sensor shall determine the following:

1. Osmotic stress (hydration) of salivary cells, and may therefore, be useful as a surrogate measure for osmolality in diagnosing fluid and electrolyte imbalances including body water deficits (dehydration) and sufeits (hyponatremia).

2. The sensor shall measure biomarkers in saliva to provide a non-invasive aid in the diagnosis of fluid-electrolyte imbalances such as dehydration. The purpose of the present contract and performance work statement (PWS) is to support the advanced development of this saliva HSM technology, including the optimization of the biomarkers to be included in the device, as well as the development of prototype device(s) to be tested.

This acquisition will allow the Contractor to develop an analysis method biomarker device (patent pending) and a report to support hydration status monitoring in the field.

This requirement is a follow-on research project for the continued development of a rapid, non-invasive device to aid in the diagnosis, treatment of dehydration, and move forward toward the final Food and Drug Administration approved product.

To maintain continuity of a current on-going approved research protocol, and validity of the scientific research, continuing development studies with GAIA is essential to the Government's mission and needs, thereby precluding consideration of exposures provided by another entity. Changing the exposure methods will change the results of the on-going research project, and will reduce the comparability of the results from previous work to the ongoing research.

Interested contractors may identify their interest and bona fide capability to fulfill the requirement. This notice of intent is not a request for competitive proposals. Interestered parties who believe they can meet this requirement shall submit information about their capabilities no later than 4:00 PM EST; Friday, 05 July 2013. All information shall be furnished at no cost or obligation to the Government. No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Telephone inquiries will not be accepted.

NOTICE OF INTENT TO SOLE SOURCE -- The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a Firm-Fixed-Price sole source award under the authority of FAR 6.302-1 (2) (c) (ii) - Only one responsible source and no other supplies will satisfy agency requirements, on or about 19 July 2013, to GAIA Medical Institute LLC, 505 Coast Blvd South, La Jolla, California 920374614 on behalf of the sponsor agency of the United States Army Medical Materiel Agency (USAMMA).

The North American Industrial Classification System (NAICS) code for this acquisition is 541711 and the size standard is 500.

The purpose of this effort is to develop a Hydration Status Monitor (HSM) sensor(s) for insertion into existing field medical equipment sets for primary use by medical personnel at the Battalion Aid Station (BAS) level. It is anticipated that the HSM will receive Food and Drug Administration (FDA) marketing clearance at the end of this contract.

The sensor shall determine the following:

1. Osmotic stress (hydration) of salivary cells, and may therefore, be useful as a surrogate measure for osmolality in diagnosing fluid and electrolyte imbalances including body water deficits (dehydration) and sufeits (hyponatremia).

2. The sensor shall measure biomarkers in saliva to provide a non-invasive aid in the diagnosis of fluid-electrolyte imbalances such as dehydration. The purpose of the present contract and performance work statement (PWS) is to support the advanced development of this saliva HSM technology, including the optimization of the biomarkers to be included in the device, as well as the development of prototype device(s) to be tested.

This acquisition will allow the Contractor to develop an analysis method biomarker device (patent pending) and a report to support hydration status monitoring in the field.

This requirement is a follow-on research project for the continued development of a rapid, non-invasive device to aid in the diagnosis, treatment of dehydration, and move forward toward the final Food and Drug Administration approved product.

To maintain continuity of a current on-going approved research protocol, and validity of the scientific research, continuing development studies with GAIA is essential to the Government's mission and needs, thereby precluding consideration of exposures provided by another entity. Changing the exposure methods will change the results of the on-going research project, and will reduce the comparability of the results from previous work to the ongoing research.

Interested contractors may identify their interest and bona fide capability to fulfill the requirement. This notice of intent is not a request for competitive proposals. Interestered parties who believe they can meet this requirement shall submit information about their capabilities no later than 4:00 PM EST; Friday, 05 July 2013. All information shall be furnished at no cost or obligation to the Government. No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Telephone inquiries will not be accepted.